A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE)

Summary

This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).

Timeline

Start

2019-03-11

Primary completion

2020-10-05

Completion

2022-01-07

Outcome

Met primary endpoint

paper BCVA change from baseline with faricimab was non-inferior to aflibercept in both TENAYA PMID 35085502 ↗

release “Both studies met their primary endpoint, with faricimab consistently shown to offer non-inferior visual acuity gains to aflibercept.” gene.com ↗

release “TENAYA and LUCERNE studies Roche's faricimab meets primary endpoint” chugai-pharm.co.jp ↗

Publications

• Results Khanani AM, Kotecha A, Chang A, Chen SJ, Chen Y, Guymer R, Heier JS, Holz FG, Iida T, Ives JA, Lim JI, Lin H, Michels S, Quezada Ruiz C, Schmidt-Erfurth U, Silverman D, Singh R, Swaminathan B, Willis JR, Tadayoni R; TENAYA and LUCERNE Investigators. TENAYA and LUCERNE: Two-Year Results from the Phase 3 Neovascular Age-Related Macular Degeneration Trials of Faricimab with Treat-and-Extend Dosing in Year 2. Ophthalmology. 2024 Aug;131(8):914-926. doi: 10.1016/j.ophtha.2024.02.014. Epub 2024 Feb 19.
• Lim JI, Ambresin A, Avery RL, Chaikitmongkol V, Eter N, Gomi F, Khanani AM, London NJS, Harrell E, Margaron P, Patel S, Souverain A, Yang M, Lai TYY. Reduction in Pigment Epithelial Detachment Thickness with Faricimab versus Aflibercept 2 mg during Head-to-Head Dosing in TENAYA/LUCERNE. Ophthalmol Sci. 2026 Mar 10;6(5):101148. doi: 10.1016/j.xops.2026.101148. eCollection 2026 May.
• Pitcher JD 3rd, Koh AHC, Tan CS, Vakharia P, Dagincourt N, Patel S, Yang M, Margaron P, Gallego-Pinazo R. Rapid Fluid Resolution and Durability With Faricimab in Neovascular Age-Related Macular Degeneration. JAMA Ophthalmol. 2026 Mar 1;144(3):269-272. doi: 10.1001/jamaophthalmol.2025.6365.
• Takahashi K, Cheung CMG, Iida T, Lai TYY, Ohji M, Yanagi Y, Kawano M, Ohsawa S, Suzuki T, Kotecha A, Lin H, Patel V, Swaminathan B, Lee WK; TENAYA, LUCERNE Investigators. Efficacy, durability, and safety of faricimab in patients from Asian countries with neovascular age-related macular degeneration: 1-Year subgroup analysis of the TENAYA and LUCERNE trials. Graefes Arch Clin Exp Ophthalmol. 2023 Nov;261(11):3125-3137. doi: 10.1007/s00417-023-06071-8. Epub 2023 Jun 9.
• Khanani AM, Guymer RH, Basu K, Boston H, Heier JS, Korobelnik JF, Kotecha A, Lin H, Silverman D, Swaminathan B, Willis JR, Yoon YH, Quezada-Ruiz C. TENAYA and LUCERNE: Rationale and Design for the Phase 3 Clinical Trials of Faricimab for Neovascular Age-Related Macular Degeneration. Ophthalmol Sci. 2021 Nov 17;1(4):100076. doi: 10.1016/j.xops.2021.100076. eCollection 2021 Dec.
• Heier JS, Khanani AM, Quezada Ruiz C, Basu K, Ferrone PJ, Brittain C, Figueroa MS, Lin H, Holz FG, Patel V, Lai TYY, Silverman D, Regillo C, Swaminathan B, Viola F, Cheung CMG, Wong TY; TENAYA and LUCERNE Investigators. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022 Feb 19;399(10326):729-740. doi: 10.1016/S0140-6736(22)00010-1. Epub 2022 Jan 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Aflibercept	Protein / enzyme biologic	2 mg	Intravitreal
Subject	Faricimab	Monoclonal antibody	6 mg	Intravitreal

Indications